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After months of hearings and debate, the House of Representatives and the Senate reached agreement earlier this week on legislation to address the opioid epidemic.  The House passed the legislation today on a vote of 393 to 8.  The Senate is expected to follow suit before adjourning to campaign for the midterm elections, and President Trump is expected to sign the bill into law.

The legislation, the “SUPPORT for Patients and Communities Act” (H.R. 6), touches on almost every aspect of the unrelenting epidemic that is affecting communities across the nation, including numerous provisions supported by the AMA that will expand access to substance use disorder prevention and treatment programs, including for pregnant women and newborns with Neonatal Abstinence Syndrome (NAS); fund research and development of non-opioid pain therapies; crack down on international shipments of illicit drugs such as fentanyl; and lift restrictions on using telemedicine for treatment for substance use disorders.  Additional provisions in H.R. 6 direct federal agencies to produce studies, reports, and guidelines related to opioid use, prescribing, and treatment.

More specifically, some of the significant AMA-supported provisions would:

  • Expand existing programs and create new programs to prevent substance use disorders and overdoses, including reauthorization of the Office of National Drug Control Policy;
  • Expand programs to treat substance use disorders, including medication-assisted treatment (MAT); partially lift (for five years) a current restriction that blocks states from spending federal Medicaid dollars on residential addiction treatment centers with more than 16 beds by allowing payments for residential substance use disorder services for up to 30 days; allow Medicare to cover MAT, including methadone, in certain setting, to treat substance use disorders; and require state Children’s Health Insurance Programs to cover mental health benefits, including substance use disorder services for eligible pregnant women and children;
  • Increase funding for residential treatment programs for pregnant and postpartum women; require the Centers for Disease Control and Prevention (CDC) to develop educational materials for clinicians to use with pregnant women for shared decision-making regarding pain management during pregnancy; and require the Department of Health and Human Services (HHS) to implement research, prevention, and treatment recommendations related to NAS in newborns.
  • Authorize an Alternative Payment Model (APM) demonstration project developed by the American Society of Addiction Medicine, with support from the AMA, to increase access to comprehensive, evidence-based outpatient treatment for Medicare beneficiaries with opioid use disorders; the APM would require demonstration participants to provide both medication as well as psychosocial supports, care management, and treatment planning for opioid use disorders for eligible beneficiaries, and also includes the development of measures to evaluate the quality and outcomes of treatment, and rewards participants for performance on such quality measures;
  • Authorize CDC grants for states and localities to improve their Prescription Drug Monitoring Programs (PDMPs), collect public health data, implement other evidence-based prevention strategies, encourage data sharing between states and support other prevention and research activities related to controlled substances, including education and awareness efforts;
  • Expand the use of telehealth services for Medicaid and Medicare substance use disorder treatment and require the Attorney General to issue final regulations within a year to provide waivers to health care providers to allow them to prescribe controlled substances via telemedicine in emergency situations;
  • Provide loan repayment for substance use disorder treatment professionals, including physicians, who agree to work in mental health professional shortage areas (HPSA) or counties that have been hardest hit by drug overdoses and clarify that mental and behavioral health providers participating in the National Health Service Corps can provide care at a school or other community-based setting located in a HPSA as part of their obligated service requirements;
  • Help stop the flow of illicit opioids into the country by mail, especially synthetic fentanyl and its analogs, which are responsible for the rise in overdose deaths;
  • Provide funding to encourage research and development of new non-addictive painkillers and non-opioid drugs and treatments;
  • Require HHS to study and report to Congress on the impact of federal and state laws and regulations that limit the length, quantity, or dosage of opioid prescriptions; and direct the Government Accountability Office to analyze and issue a report to Congress on the barriers to access to substance use disorder treatment medications under various drug distribution models, as well as addressing options for state Medicaid programs to reduce or remove such barriers; and direct the Medicaid and CHIP Payment and Access Commission to conduct a study on utilization management controls applied to MAT options in both fee-for-service and managed care Medicaid programs; and
  • Require the Department of Labor, in collaboration with the Centers for Medicare & Medicaid Services (CMS) and the Secretary of the Treasury, to provide additional information in annual reports to Congress on mental health parity compliance.

The final bill also retained some provisions that the AMA raised concerns with, primarily related to mandates on physicians and duplicative requirements on state and federal programs. One would create a federal mandate for physicians to electronically prescribe controlled substances (EPCS) by January 2021 for prescriptions for Schedule II, III, IV, and V controlled substances covered under a Medicare Part D Prescription Drug Plan or Medicare Advantage (MA) Prescription Drug Plan. The final language did, however, include the requirement that the Drug Enforcement Administration update its regulations pertaining to how prescribers authenticate prescriptions using biometrics to keep up with changing technology. Another provision that the AMA raised concerns with requires the Secretary of HHS to establish a standard, secure electronic prior authorization system (ePA) for covered Part D and MA drugs but allowed plans to continue to operate their individual proprietary online portals.  Another provision requires the Food and Drug Administration (FDA) to develop prescribing guidelines for the indication-specific treatment of acute pain where such guidelines do not exist. However, the AMA is pleased that a provision was retained that requires the FDA Commissioner to publish a clear statement of intent to accompany the guidelines stating that such guidelines are intended to inform clinical decisions by prescribers and patients and are not intended to restrict, limit, delay or deny coverage or access by individual health care professionals.

One proposal that is not in the final legislation would remove patient privacy protections under federal law related to the confidentiality of substance use disorder records. The AMA opposed the efforts to include this proposal partly out of concern that allowing more access to such records could discourage patients from seeking treatment for substance use disorder. However, the AMA is committed to continuing to work with Congress and other stakeholders to develop a solution that balances the need for health professionals to have the information they need to provide appropriate treatment to patients with substance use disorder, while ensuring appropriate privacy protections for patients.

AMA Advocacy staff will continue to strongly advocate our policy priorities at the federal and state levels as the numerous provisions in H.R. 6 are implemented.

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